Mallinckrodt Initiates Phase IV Study On Acthar For Keratitis

 | Dec 16, 2019 10:25PM ET

Mallinckrodt plc (NYSE:MNK) announced the enrollment of the first patient in its phase IV, multi-center, multiple-dose, open-label study to assess the effects of lead drug Acthar Gel as a therapy option in patients with severe keratitis. Keratitis is a painful inflammation of the cornea, which can result in partial or total loss of vision if left untreated.

The study targets to enroll 30 adult subjects to examine the effects of Acthar. Subjects with current severe keratitis, who meet entry criteria, will be treated with Acthar Gel 1 mL subcutaneously (SC) two times per week for 12 weeks. Initial treatment will be followed by a taper to Acthar 1 mL SC once a week for two weeks, then 0.5 mL SC once a week for two weeks.

Label expansion of the drug will boost sales for the company.

Mallinckrodt’s stock has plunged 76.9% in the year so far against the Zacks Investment Research

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